Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

159 results for "Miles Laboratories, Inc."
25–48 of 159
Search insights Median review: 38d Cleared: 100% Top manufacturer: Miles Laboratories, Inc. Lead specialty: Chemistry
Cleared Aug 07, 1985
OPTIMATE DIGOXIN TEST
K853021 · DPB
Miles Laboratories, Inc.
Toxicology · 20d
Cleared Jun 10, 1985
CYTO-TEK CENTRIFUGE
K852117 · IFB
Miles Laboratories, Inc.
Pathology · 26d
Cleared Mar 19, 1985
SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &
K844955 · CEM
Miles Laboratories, Inc.
Chemistry · 88d
Cleared Mar 19, 1985
SERALYZER ARIS PHENYTOIN REAGENT STRIPS
K842092 · DIP
Miles Laboratories, Inc.
Toxicology · 299d
Cleared Jan 18, 1985
CLINIFACTS 10 DATA MANAGEMENT SYSTEM
K844907 · JQP
Miles Laboratories, Inc.
Chemistry · 32d
Cleared Jan 04, 1985
LEUKOSTIX REAGENT STRIPS FOR URINALYSIS
K843727 · LJX
Miles Laboratories, Inc.
Chemistry · 102d
Cleared Aug 28, 1984
TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM
K842470 · DFH
Miles Laboratories, Inc.
Immunology · 64d
Cleared Aug 28, 1984
TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG
K842468 · CZP
Miles Laboratories, Inc.
Immunology · 64d
Cleared Aug 24, 1984
CLINI-TEK AUTO 2000 REFLECTANCE SPECTR
K841041 · KQO
Miles Laboratories, Inc.
Chemistry · 165d
Cleared Aug 17, 1984
AMES TDA PHENOBARBITAL TEST
K842592 · LET
Miles Laboratories, Inc.
Toxicology · 45d
Cleared Aug 15, 1984
CLINITEK 200 SEMI-AUTOMATED URINALYSIS
K842237 · KQO
Miles Laboratories, Inc.
Chemistry · 71d
Cleared Jul 25, 1984
CLINITEK 10 SEMI-AUTO URINALYSIS SYS
K842238 · KQO
Miles Laboratories, Inc.
Chemistry · 50d
Cleared Jul 16, 1984
CITOJECT CARTRIDGE SYRINGE
K842006 · EJI
Miles Laboratories, Inc.
Dental · 60d
Cleared Jun 22, 1984
OPTIMATE IGG TEST
K841816 · DEW
Miles Laboratories, Inc.
Immunology · 52d
Cleared Jun 22, 1984
OPTIMATE IGM TEST
K841814 · DFT
Miles Laboratories, Inc.
Immunology · 52d
Cleared Jun 01, 1984
OPTIMATE IGA TEST
K841815 · CZN
Miles Laboratories, Inc.
Immunology · 31d
Cleared May 11, 1984
OPTIMATE DIGOXIN TEST
K841582 · KXT
Miles Laboratories, Inc.
Toxicology · 24d
Cleared Mar 19, 1984
SERALYZER DRUG ASSAY CONTROL SERUM
K833977 · DLJ
Miles Laboratories, Inc.
Toxicology · 123d
Cleared Mar 19, 1984
SERALYZER THEOPHYLLINE REAGENT STRIPS
K832825 · KLS
Miles Laboratories, Inc.
Toxicology · 213d
Cleared Oct 28, 1983
AMES TDA NETILMICIN TEST & SERUM
K832088 · LCE
Miles Laboratories, Inc.
Chemistry · 122d
Cleared Oct 14, 1983
SERAYZER ALT/SGPT REAGENT STRIPS
K832791 · CKC
Miles Laboratories, Inc.
Chemistry · 56d
Cleared Oct 14, 1983
SERALYZER AST/SGOT REAGENT STRIPS
K832790 · CIF
Miles Laboratories, Inc.
Chemistry · 59d
Cleared Oct 04, 1983
SERALYZER TRIGLYCERIDES REAGENT STRIPS
K832684 · CDT
Miles Laboratories, Inc.
Chemistry · 56d
Cleared Sep 29, 1983
AMES TDA SISOMICIN TEST-CONTROL SERUM
K832792 · DJB
Miles Laboratories, Inc.
Chemistry · 44d